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Objective The aim was to test the feasibility of a randomized controlled trial exploring whether omega-3 fatty acid supplementation limits gout flares during treat-to-target urate-lowering treatment (T2T-ULT). Methods Adults with at least one gout flare in the past 12 months and serum urate (SU) ≥360 μmol/l were recruited from general practices (primary method) and randomly assigned 1:1 to receive omega-3 fatty acid supplementation (4 g/day) or placebo for 28 weeks. At week 5, participants began T2T-ULT. The primary outcome was drop-out rate. Secondary outcomes were recruitment rate, outcome data completeness, the number, severity and duration of gout flares between weeks 5 and 28, and study drug compliance. Results Ninety-five per cent of randomized participants (n = 60) completed all study visits. The primary method recruitment rate was 2.2%. Fifty and 42 participants achieved SU Conclusion The study demonstrated feasibility and provided useful metrics for conducting a community-based gout flare prophylaxis trial. Study registration ISRCTN; https://www.isrctn.com/; ISRCTN79392964.

Objectives The overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first phase, we examined the acceptability of the non-pharmacological component of the intervention; issues faced in delivery, and resolved possible challenges to delivery. Methods Eighteen adults with chronic knee pain were recruited from the community. The intervention comprised holistic assessment, education, exercise, weight-loss advice (where appropriate) and advice on adjunctive treatments such as hot/cold treatments, footwear modification and walking aids. After nurse training, the intervention was delivered in four sessions spread over five weeks. Participants had one to one semi-structured interview at the end of the intervention. The nurse was interviewed after the last visit of the last participant. These were audio recorded and transcribed verbatim. Themes were identified by one author through framework analysis of the transcripts, and cross-checked by another. Results Most participants found the advice from the nurse easy to follow and were satisfied with the package, though some felt that too much information was provided too soon. The intervention changed their perception of managing knee pain, learning that it can be improved with self-management. However, participants thought that the most challenging part of the intervention was fitting the exercise regime into their daily routine. The nurse found discussion of goal setting to be challenging. Conclusion The nurse-led package of care is acceptable within a research setting. The results are promising and will be applied in a feasibility randomised-controlled trial.

Introduction: Although calcium pyrophosphate deposition (CPPD) is common, there are no published outcome domains or validated measurement instruments for CPPD studies. In this paper, we describe the framework for development of the Outcome Measures in Rheumatology (OMERACT) CPPD Core Domain Sets. Methods: The OMERACT CPPD working group performed a scoping literature review and qualitative interview study. Generated outcomes were presented at the 2020 OMERACT CPPD virtual Special Interest Group (SIG) meeting with discussion focused on whether different core domain sets should be developed for different calcium pyrophosphate deposition (CPPD) clinical presentations and how the future CPPD Core Domain Set may overlap with already established osteoarthritis (OA) domains. These discussions informed development of a future work plan for development of the OMERACT CPPD Core Domain Sets. Findings: Domains identified from a scoping review of 112 studies and a qualitative interview study of 36 people (28 patients with CPPD, 7 health care professionals, one stakeholder) were mapped to core areas of OMERACT Filter 2.1. The majority of SIG participants agreed there was need to develop separate core domain sets for "short term" and "long term" studies of CPPD. Although CPPD + OA is common and core domain sets for OA have been established, participants agreed that existing OA core domain sets should not influence the development of OMERACT core domain sets for CPPD. Prioritization exercises (using Delphi methodology) will consider 40 potential domains for short term studies of CPPD and 47 potential domains for long term studies of CPPD. Conclusion: Separate OMERACT CPPD Core Domain Sets will be developed for "short term" studies for an individ-ual flare of acute CPP crystal arthritis and for "long term" studies that may include participants with any clinical presentation of CPPD (acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and/or CPPD + OA). (c) 2021 Elsevier Inc. All rights reserved.

ObjectivesTo evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain.SettingSecondary care. Single-centre study.Study designMixed methods study.ParticipantsEighteen adults with chronic knee pain.Inclusion criteriaAge >40 years, knee pain present for longer than 3 months, knee pain for most days of the previous month, at least moderate pain in two of the five domains of Western Ontario and McMaster Universities Osteoarthritis Index pain scale.InterventionsNurse-led non-pharmacological intervention comprising assessment, education, exercise, use of hot/cold treatments, footwear modification, walking aids and weight-loss advice (if required).Outcome(s)Primary: fidelity of delivery of intervention, secondary: nurses’ experience of delivering intervention.MethodsEach intervention session with every participant was video recorded and formed part of fidelity assessment. Fidelity checklists were completed by the research nurse after each session and by an independent researcher, after viewing the video-recordings blinded to nurse ratings. Fidelity scores (%), percentage agreement and 95% Confidence Intervals (CI) were calculated. Two semi-structured interviews were conducted with the research nurse.ResultsFourteen participants completed all visits. 62 treatment sessions took place. Nurse self-report and assessor video rating scores for all 62 treatment sessions were included in fidelity assessment. Overall fidelity was higher on nurse self-report (97.7%) than on objective video-rating (84.2%). Percentage agreement between nurse self-report and video-rating was 73.3% (95% CI 71.3 to 75.3). Fidelity was lowest for advice on footwear and walking aids. The nurse reported difficulty advising on thermal treatments, footwear and walking aids, and did not feel confident negotiating achievable and realistic goals with participants.ConclusionsA trained research nurse can deliver most components of a non-pharmacological intervention for knee pain to a high degree of fidelity. Future research should assess intervention fidelity in a routine clinical setting, and examine its clinical and cost-effectiveness.Trial registration numberNCT03670706.

Introduction: Although calcium pyrophosphate deposition (CPPD) disease is common, there are no validated outcome measures for clinical research in this condition. The aim of this study was to generate a list of outcome domains as reported by patients, their caregivers, healthcare professionals (HCPs) and stakeholders to inform the development of an Outcome Measures in Rheumatology (OMERACT) Core Domain Set for CPPD. Methods: Patients with CPPD and their caregivers, HCPs and stakeholders took part in semi-structured qualitative interviews to explore potential outcome domains for CPPD clinical research relevant to their lived experience and knowledge of CPPD. Interviews were conducted in six countries across three continents. Data was analysed using manifest content analysis to identify outcome domains, which were tabulated and mapped to the core areas as defined by the OMERACT Filter 2.1. Results: Thirty-six interviews were conducted in total. Participants comprised of 28 patients (six of which included a caregiver), seven HCPs and one stakeholder. The commonly identified (sub-) domains (d) across the 1) abnormalities/manifestations core area were joint pain (d = 35), joint swelling (d = 27), joint stiffness (d = 25), CPPD flares (d = 25); 2) life-impact core area were overall function (d=35), and specifically the ability to complete daily tasks (d = 25); and 3) societal/resource use core area were use of analgesic medicines (d = 26). Patients more commonly reported joint swelling, stiffness and range of movement, and use of analgesics while HCPs more commonly reported domains relating to presence of CPP crystals, radiologic calcification, joint damage, time to diagnosis and suitability of treatment. Conclusion: Among a number of potential outcome domains identified, articular manifestations, function and analgesic use were most frequently mentioned by participants. These findings will be used to develop an OMERACT Core Domain Set for CPPD. (C) 2021 Elsevier Inc. All rights reserved.

Objective: To explore the lived experience of people with calcium pyrophosphate deposition (CPPD) disease and the impact of this condition on their daily lives. Methods: Patients with CPPD and their caregivers were invited to take part in a one-to-one (patient only) or paired (patient and caregiver) semi-structured interview. Interviews covered patients' diagnosis and treat-ment experiences, and the impact of CPPD on their daily lives. Transcribed interviews were analysed using inductive thematic analysis. Results: 28 patient interviews, six of which included a caregiver, were conducted across five countries. Acute CPP crystal arthritis flares resulted in temporary but profound disability for most patients, disrupting their ability to go about day-to-day activities, and they sought immediate medical attention. CPPD+OA and chronic CPP crystal inflammatory arthritis presented patients with longer term limitations in daily lives. Patients and their caregivers described these disruptions and limitations, which included a reduced ability or inability to complete household and self-care tasks, exercise, socialise, work and drive. They also described how arthritis pain and resulting limitations adversely impacted upon patients' psychological wellbeing. Delays in referral to specialists and diagnostic uncertainty were described by many. Lack of appropriate treatment or access to treatments only upon worsening of symptoms impacted upon the length of time some patients spent in pain and with functional limitations. Conclusion: This study is the first to demonstrate the wide-ranging impact of CPPD, and highlights the need for improved diagnosis, physician training, as well as greater emphasis upon finding targeted therapies to specifically treat CPPD. (c) 2021 Elsevier Inc. All rights reserved.

IntroductionKnee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.Methods and analysisIn phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.Ethics and disseminationThis protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.Trial registration numberNCT03670706

Introduction Although calcium pyrophosphate deposition (CPPD) is common, there are no validated outcome domains and/or measurements for CPPD studies. The aim of this work was to identify domains that have been reported in prior clinical studies in CPPD, to inform the development of a core set of domains for CPPD studies. Methods We performed a scoping literature review for clinical studies in CPPD, searching in Medline (via PubMed), EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases; published from January 1, 1946 to January 7, 2020. All reported outcomes and study design data were extracted and mapped to the core areas and domains as defined by the OMERACT Filter 2.1.The protocol was registered on PROSPERO (CRD: 42019137075; 09-07-2019). Findings There were 112 papers identified, comprising of 109 observational studies and three randomized controlled trials. Most studies reported clinical presentations of OA with CPPD or acute CPP crystal arthritis. Outcomes that mapped to 22 domains were identified; the most frequently reported measures mapped to the following domains/sub-domains: imaging (joint damage on imaging tests - 59 studies; joint calcification on imaging tests - 28 studies), joint pain (26 studies), response to treatment (23 studies), side effects of treatment (15 studies), inflammation in the joint fluid or blood (ESR or C-reactive protein - 12 studies; synovial fluid markers - 4 studies; other blood markers - 2 studies), overall function (14 studies), joint swelling (12 studies) and range of joint movement (10 studies). Very few studies mapped to domains related to life impact, societal/resource use or longevity. Conclusion There is substantial variability in outcomes reported in CPPD studies. Outcomes that map to imaging manifestations, joint pain and response to treatment domains are most often reported.

Objectives To explore patient satisfaction, gout knowledge, medication adherence and flares among participants receiving nurse-led or general practitioner (GP)-led care of gout in the Nottingham Gout Treatment Trial phase-II (NGTT-II). Methods A total of 438 participants of NGTT-II were sent a questionnaire enquiring about gout knowledge, satisfaction with health-care practitioner, urate-lowering treatment being undertaken, and gout flares ⩾1 year after their final visit. Nurse-led care participants were asked about their preference for receiving gout treatment from either a GP or a nurse. Results Completed questionnaires were returned by 82% of participants. Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0 (0–0) vs 1 (0–3), P < 0.001] than those receiving GP-led care. Of participants receiving nurse-led care, 41–63% indicated preference for receiving gout treatment from a nurse, while only 5–20% indicated preference for receiving treatment from GPs. Conclusion The results of this study favour nurse-led care, involving individualized patient education and engagement and a treat-to-target strategy, in terms of patient acceptability, long-term adherence, and flares. Further research is required to evaluate the feasibility of implementing such a model of care in clinical practice.

Background:The role of nurses in managing painful knee OA has been advocated but whether nurses can deliver such interventions as a package of care is unknown.The overall aim of this research is to develop and test a nurse-led complex intervention for knee pain comprising non-pharmacological and pharmacological components. In the first study phase, we report on fidelity and acceptability of a non-pharmacological intervention, to resolve possible challenges to delivery.Objectives:To evaluate fidelity of delivery and acceptability of non-pharmacological components of a complex intervention.Methods:This was a mixed-methods study. Participants with chronic knee pain were recruited from the community to receive the intervention, delivered in 4-sessions over a 5-week period by a trained research nurse. The intervention consisted of holistic assessment, patient education and advice, aerobic and strengthening exercise and weight-loss advice if required. All sessions were video-recorded. Fidelity checklists were completed by the nurse (nurse-rated) and two researchers from the video-recordings (video-rated). Median fidelity scores (%) and interquartile ranges (IQR) were calculated for each component and each session. Semi-structured interviews were conducted with participants. These were audio recorded, transcribed and analysed following the framework approach.Results:18 participants (34% women), with a mean (SD) age and BMI of 68.7 (9.0) years and 31.2 (8.4) kg/m2, took part in the study. Of these, 14 completed all visits. In total, 62 intervention sessions were assessed for fidelity. Overall fidelity was rated high by both nurse-rated scores (97.7%) and video-rated scores (84.2%). The level of agreement between nurse-rated and video-recorded methods was 73.3% (CI 71.3, 75.3) and the inter-rater agreement was 65.5% (CI 60.3, 70.5). Fidelity of delivery was lower for advice on footwear modification and walking aids in all sessions and moderate for education in session 1 and for exercise in session 4 (Table 1).Table 1.Fidelity scores of the components of the intervention for each session,Intervention componentsSession 1*Session 2*Session 3*Session 4*Education78.1 (74.1, 93.7)87.5 (50, 100)87.5 (50, 100)100 (93.7, 100)Exercise94.4 (88.9, 100)88.9 (75, 94)86.1 (72, 100)75 (67.6, 82.8)Adjunctive treatments50 (45.83, 100)0 (0, 50)50 (0, 100)-*median (IQR)17 participants were interviewed. Most found advice supplied straightforward. They were satisfied with the package, which changed their perception of managing knee pain, understanding it can be improved though self-management. However, too much information was provided in a short time-span and it was difficult to fit exercises into their daily routine.Conclusion:Delivery of a non-pharmacological intevention by a nurse is feasible within a research setting. Most components of the intervention were delivered as intended, except for advice about the use of adjunctive treatment.Acknowledgments:This research was funded by the NIHR Nottingham BRC and Pain Centre Versus ArthritisDisclosure of Interests:Polykarpos Angelos Nomikos: None declared, Amy Fuller: None declared, Michelle Hall: None declared, Bonnie Millar: None declared, Reuben Ogollah: None declared, Michael Doherty: None declared, Roshan Nair Speakers bureau: Financial support from pharmaceutical companies (Biogen and Novartis) to present lectures at events related to psychological support for people with multiple sclerosis (Speaker’s bureau)., David Walsh Grant/research support from: 2016: Investigator-led grant from Pfizer Ltd (ICRP) on Pain Phenotypes in RA; non-personal financial disclosure (payment to University)., Consultant of: DAW has undertaken paid consultancy to Pfizer Ltd, Eli Lilly and Company and GSK Consumer Healthcare., Paid instructor for: 2019: Consultancy to Love Productions; consultancy on programme design, contribution to programme content on self-management of chronic pain (payments to University)2019: Consultancy to AbbVie Ltd; 13.06.19; presentation on RA pain at EULAR, Madrid, and webinar (payments to University).2019: Consultancy to Eli Lilly and Company Ltd. 06.06.19 Centre for Collaborative Neuroscience, Windlesham, Surrey, UK (payment to University).2019: Consultancy to Pfizer (payment to University).2018: Consultancy to Pfizer. 07.12.18. USA. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 23.11.18. Manchester UK. 1 day. Tanezumab (payment to University).2018: Consultancy to Pfizer. 1.11.18. Skype. 4h. Tanezumab (payment to University).2018: Consultancy to GlaxoSmithKline Plc. 1 day. Pain in RA and anti-GM-CSF (payment to University).2018: Consultancy to Pfizer Ltd; Presentation at OARSI; non-personal financial disclosure (payment to University)2018: Consultancy to Pfizer Ltd; Patient preference study; non-personal financial disclosure (payment to University)2017: Consultancy to Pfizer Ltd; personal financial disclosure2017: Consultancy to Pfizer Ltd through Nottingham University; non-personal financial disclosure (payment to University).2015: Consultancy to GSK Consumer Healthcare; personal financial disclosure., Speakers bureau: 2019: Irish Society of Rheumatology: speaker fees (personal pecuniary), Ana Valdes Grant/research support from: Awarded a grant from Pfizer, Abhishek Abhishek: None declared